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D. Lavinsky, J. A. Cardillo, A. A. S. Lima filho, R. Costa, A. A. Silva Jurnior, R. Belfort, Jr., A. G. Oliveira; Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2698.
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Phase I/II study with intravitreal triamcinolone acetonide microspheres (RETAAC) for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient.
Patients were assigned into treatment group that received intravitreal biodegradable (lactic-co-glycolic acid polymer) sustained-release triamcinolone microspheres system (RETAAC). Efficacy was evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 1, 3, 6 and 12 months of treatment. We also performed confocal scanning laser ophthalmoscopy of the vitreous to identify the presence and behavior of microspheres system.
Twenty one patients were included in this study. No procedure related complications occured and the only adverse event was increased intraocular pressure controlled in all cases with topical antiglaucomatous medications. Confocal scanning laser ophthalmoscopy was able to identify the microspheres and using infrared high-speed, high-resolution movie we could demonstrate the behavior of the system in the vitreous, its mobility and dynamicaly observe its interference on the macula. Microspheres remained visible for one year. Quantitative measurements of central macular thickness (CMT) by OCT showed a reduction from baseline exceeding 59% (RETAAC) at 3 months, which remained at 6 and 12 months. We could not identify significant improvement in visual acuity, although there was no significant loss of vision.
RETAAC was safe for the one year observation period, with no serious adverse event and also appeard to have a positive eficacy profile. Targeting chronic diseases, a rationale for RETAAC as promising approach for the intraocular delivery of drugs is suggested, and as experience grows guided by the results of larger randomized clinical trials , the precise role of this innovative approach may become more defined.
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